Clinical trials typically involve numerous subjects, many test sites, extensive planning and coordination, and are very expensive to run. Pharmaceutical development continues to be under pressure to reduce operational costs while maintaining or increasing scientific values. In recent years, one approach to reducing costs of clinical trials is using electronic data capture (EDC) rather than recording all trial data on paper. Another approach is to remotely monitor some sites, rather than sending site monitors to physically visit all sites to confirm adherence to the design of the trial and/or good clinical practice.
One area of clinical development that has not been adequately addressed is the coordination of various sources of data from across different clinical trials and even different sponsors in order to facilitate future trials. For example, starting up a trial, which involves selecting appropriate sites, investigators and subjects, remains a laborious and oftentimes repetitive task for trial sponsors (pharmaceutical companies), or their contract research organizations (CROs). Similarly, with appropriate data coordination, site and investigator collaboration may be enabled, and through feedback from other PIs or site personnel, improved protocol design collaboration may be facilitated.
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